Creso Pharma’s Halucenex engages HeteroGeneity ahead of US entry
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In an important commercial development, Creso Pharma Limited’s (ASX:CPH, FRA:1X8) target acquisition company Halucenex Life Sciences Inc. has entered into a consultancy agreement with leading US-based scientific consultancy HeteroGeneity, LLC to progress a US market entry strategy for the potential use and licensing of the company’s botanical psilocybin products and compounds.
The agreement will assist in commencing licensing discussions with large pharmaceutical groups ahead of phase II clinical trials, in management’s view, a key factor in establishing a considerable competitive advantage.
HeteroGeneity is a scientific management organisation based in Washington DC that provides strategic and technical assistance to clients conducting research, development and commercialisation of drugs, biologics and medical devices for the US and Canadian markets.
The group specialises in the regulation, policy and science of complex, heterogeneous mixtures, while also addressing novel use areas for traditional medicine practice and naturally of historically complex products.
HeteroGeneity is at the forefront of regulation in North America and has been instrumental in assisting a number of companies achieve New Drug Approval Applications through the Food and Drug Administration (FDA) for the US market.
Under the agreement, both parties will conduct a technology assessment to progress a development plan for a new botanical drug under pharmaceutical development for the US market.
This will include advisory around clinical indications, regulatory status of proposed ingredients, sourcing, manufacturing and formulation, compilation of supporting data and intellectual property considerations amongst other initiatives.
HeteroGeneity shall be compensated on an hourly basis, and may be terminated without cause by either party upon giving 30 days written notice.
Strategically important in entering US market
The agreement marks an important first step in the company’s US market entry strategy.
HeteroGeneity will assist Creso Pharma and Halucenex with any required FDA regulatory approvals, and will enable Creso to start discussions with large-scale pharmaceutical companies around licensing agreements for its extracts and psychedelic compounds.
Based on independent research, the psychedelic therapeutic drug market in the US is expected to reach a total value of US$6.7 billion by 2027, making it a very lucrative opportunity for Creso Pharma.
Ahead of the pending phase II clinical trial, Halucenex has assembled a market-leading team of consultants and strategic partners, providing the group with a considerable competitive advantage as it progresses clinical trials and positions for entry into the US market, subject to necessary legislative reform.
Creso Pharma sees the prospect of entering the US market as a very positive step, and on this note non-executive chairman Adam Blumenthal said, “Creso’s Board and management are very pleased that Halucenex is taking steps forward in the early stages to progress a US market entry.
“Having centralised operations in Nova Scotia will provide Halucenex with considerable advantages when undertaking the steps required to progress regulatory approvals and potential discussions with large pharmaceutical groups for the licensing of the group’s psilocybin extracts and compounds.”
tagsFDA FDA APPROVAL APPLICATIONS HETEROGENEITY PSYCHEDELICS PHASE II TRIALS HALUCENEX LIFE SCIENCES
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